Monthly Archives: May 2019
No CE mark? No problem.
Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading
Posted in E-Health/Technology, FDA, Regulatory Services, TGA
Tagged FDA, Medical Device, Regulatory Affairs, Regulatory Services, TGA
Comments Off on No CE mark? No problem.
